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Completed

NCT Number: NCT03127410

Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study

The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University-Dallas

Dallas, Texas, 75235, United States

About this study

The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction. The central hypothesis of this pilot study is that a cluster of lumbopelvic stress tests will be able to identify a subgroup of patients with low back pain who will respond favorably to mechanical lumbar traction. If these clinical tests can identify a subgroup of patients with low back pain who respond favorably to lumbar traction, additional studies, including randomized clinical trials will be necessary to further test and validate the use of this cluster of clinical tests. The rationale for this research is to examine the connection between provocative lumbar compression testing and lumbar traction as a means of decompression

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complaints of low back pain with or without pain into the lower extremities
  • Pain of at least 2/10 according to the Numeric Pain Rating Scale
  • Score of at least 20 or greater on the Oswestry Disability Index

Exclusion criteria

  • Medical red flags consistent with non-mechanical back pain (i.e. recent weight loss, history of cancer, night sweats, fever)
  • Previous surgery to the lumbar spine
  • Current pregnancy
  • Any neurological symptoms in the lower extremities
  • Evidence of central nervous system involvement
  • The inability to lie prone for 15 minutes

Treatment and study plan

Lumbar traction

Other

Lumbar traction is used to decompress the spinal structures and relieve pressure and may stretch the spine.

Primary outcomes

  1. Change in Disability

    Time frame: 14 days

    Modified Oswestry Disability Index

Secondary outcomes

  1. Change in Pain

    Time frame: 14 days

    Numeric Pain Rating Scale

  2. Change in perceived outcome

    Time frame: 14 days

    Global Rating of Change

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2017
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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